Coronavirus Disease 2019
Conditions
Interventions
Product Name: mRNA-1273.214
Product Code: mRNA-1273.214
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intramuscular use
Sponsors
ModernaTX, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participant is male or female, between 2 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Participant has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of study drug or has a known close contact in the past 2 weeks to someone diagnosed with SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19). Participants may be rescreened after 14 days provided that they remain asymptomatic. • Participant is acutely ill or febrile 72 hours prior to or at the Screening Visit. Fever is defined as a body temperature =38.0°Celcius/=100.4°Farenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. • Participant has previously been administered an investigational or approved CoV (for example, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome-CoV) vaccine. • Participant has undergone treatment with investigational or approved agents for prophylaxis against COVID-19 (for example, receipt of SARS-CoV-2 monoclonal antibodies) within 90 days prior to enrollment. • Participant has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to any of the components of messenger ribonucleic acid COVID-19 vaccines (including polyethylene glycol or immediate allergic reaction of any severity to polysorbate). • Participant has a medical, psychiatric, or occupational condition, that, according to the investigator’s judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results. • Participant has a history of diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety. • Participant has received the following: a. Any routine vaccination with inactivated or live vaccine(s) within 14 days prior to first or second vaccination or plans to receive such a vaccine within 14 days of any study vaccination. b. Systemic immunosuppressants or immune-modifying drugs (including maternal use during pregnancy or lactation) for >14 days in total within 6 months prior to the day of enrollment (for corticosteroids, = 1 mg/kg/day or, if participant weighs >10 kg: =10 mg/day prednisone equivalent). Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids are allowed. c. Intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to enrollment. • Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit or plans to do so while participating in this study, or maternal participation in an interventional clinical study during pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study will evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 SARS-CoV-2 vaccine in infants aged 12 weeks to < 6 months.;Secondary Objective: • To evaluate the immunogenicity of 2 dose levels1 of mRNA-1273.214 vaccine administered as 2 doses 8 weeks apart in participants aged 12 weeks to < 6 months • To evaluate the immune response against SARS-CoV-2 variants of concern (Omicron) elicited by mRNA-1273.214 vaccine administered as 2 doses 8 weeks apart in participants aged 12 weeks to < 6 months, compared with the immune responses against original strain induced by mRNA-1273 primary series (2 doses 28 days apart) • To evaluate the immune response against SARS-CoV-2 original strain elicited by mRNA-1273.214 vaccine administered as 2 doses 8 weeks apart in participants aged 12 weeks to < 6 months, compared with the immune responses against original strain induced by mRNA-1273 primary series (2 doses 28 days apart);Primary end point(s): • Number of Participants with Solicited Local and Systemic Adverse Reactions • Number of Participants with Unsolicited Adverse Events (AEs) • Number of Participants with Serious AEs, Medically Attended AEs, AEs Leading to Withdrawal, and AEs of Special Interest • Geometric Mean Titer (GMT) of SARS-CoV-2 Antibodies Against Omicron Variant • Seroresponse Rate Against SARS-CoV-2 Omicron Variant;Timepoint(s) of evaluation of this end point: • Up to Day 64 (7 days after each vaccination) • Up to Day 85 (28 days after each vaccination) • Up to Day 422 • Day 85 (28 days after the second vaccination) • Day 85 (28 days after the second vaccination) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 1) • GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 2) • Seroresponse Rate Against SARS-CoV-2 Omicron Variant (Part 2) • GMT of SARS-CoV-2 Antibodies Against Original Strain (Part 2) • Seroresponse Rate Against SARS-CoV-2 Original Strain (Part 2);Timepoint(s) of evaluation of this end point: • Day 85 (28 days after the second vaccination) • Day 85 (28 days after the second vaccination) • Day 85 (28 days after the second vaccination) • Day 85 (28 days after the second vaccination) • Day 85 (28 days after the second vaccination) | — |
Countries
Argentina, Brazil, Colombia, Guatemala, Kenya, Mexico, Panama, Singapore, South Africa, United States
Contacts
Public ContactModerna Clinical Trials
ModernaTX, Inc.
Outcome results
None listed